Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing. - Full Text View

Purpose

At Beckman Laser Institute, University of California, Irvine, we have developed diagnostic device call 'Optical Coherence tomography (OCT)'.

OCT is an imaging technique capable of performing high-resolution,cross-sectional imaging. OCT enables real-time, in situ visualization of tissue microstructure without the need to excise and process the specimen as required for conventional biopsy and histopathology.

OCT is analogous to ultrasound except that imaging is performed with light instead of acoustic waves. OCT measures light reflected from turbid structures. Consequently, OCT is a powerful method to image biological tissue in-vivo at high resolution.

The objective of the study is to demonstrate a healing response in coiled aneurysms using OCT imaging at three months. The healing process constitutes fibrosis, and organization of the coiled aneurysm as well as re-endothelization.

Condition	Intervention
Aneurysm	Device: OCT

MedlinePlus related topics:

Aneurysms

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing.

Further study details as provided by University of California, Irvine:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	January 2007
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Device: OCT OCT image during angiogram procedure

Detailed Description:

Subjects presenting with subarachnoid hemorrhage secondary to ruptured cerebral aneurysms as well as subjects with unruptured aneurysms that are being treated using endovascular coiling will be included in the study.

An image will be acquired by the Optical Coherence Tomography (OCT) at the rime of initial angiography in subjects with unruptured aneurysms, and at the three month follow up catheter angiogram for all subjects. Patients with acutely ruptured aneurysms will not be investigated with OCT at the initial intervention. Images obtained at three month follow up will be analyzed for aneurysm healing based on the presence of a membranous covering or endothelization.

Endovascular therapeutic coiling is a widely used procedure in the management of aneurysms, which is an angiogram . Following therapeutic coiling of the aneurysm the 6F endocatheter and the microcatheter used for the coiling procedure will be left in place in the internal carotid artery and parent artery lumen respectively. The OCT fiber will be inserted through the lumen of the tube on which the images will be obtained.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

primary care clinic

Criteria

Inclusion Criteria:

Age ≥18 years of age
Subject diagnosis of Aneurysm and undergoing endovascular coiling

Exclusion Criteria:

Pregnant women
Age ≤18 years of age
Patient presenting emergently with acutely ruptured aneurysms

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556309

Locations


United States, California
	Neurosurgery department, University of California,Irvine
	Irvine, California, United States, 92612
	Beckman Laser Institute,University of California, Irvine
	Irvine, California, United States, 92612

Sponsors and Collaborators

University of California, Irvine

Beckman Laser Institute Medical Clinic

Neurosurgery department,University of California,Irvine, Orange.

Investigators


Principal Investigator:	Marlon S. Mathews,, MD	Beckman Laser Institute, University of Caliofrnia,Irvine

More Information

Responsible Party:	Beckman Laser Institute ( Marlon S. Mathews,, MD )
Study ID Numbers:	RR-01192;NIH-NCRR, NIH-LAMMP
First Received:	November 7, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00556309
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Aneurysm

Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 15, 2008

Sponsors and Collaborators:	University of California, Irvine Beckman Laser Institute Medical Clinic Neurosurgery department,University of California,Irvine, Orange.
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00556309